At the Charing Cross (CX) Symposium 2024 (23–25 April, London, UK), Andrew Bradbury (University of Birmingham, Birmingham, UK) and the BASIL-3 team of triallists will address the pressing question of which endovascular strategy wins in the disputed femoropopliteal segment. The investigators will be presenting—for the very first time—the results of this long-awaited, only completed, fully publicly funded randomised controlled trial (RCT) in the space.
The BASIL-3 team will reveal clinical and cost-effectiveness data comparing three alternative femoropopliteal endovascular revascularisation strategies—plain balloon angioplasty with or without bail-out bare metal stent, drug-coated balloon with or without bail-out bare metal stent, and drug-eluting stent—for the management of severe limb ischaemia (chronic limb-threatening ischaemia [CLTI]).
“They’re actually very different technologies,” Bradbury points out to Vascular News ahead of CX 2024. “So, when we set up BASIL-3, we thought it was very important to have a three-arm trial so that we could compare these three different endovascular strategies. And, we’ve been able to do that; we’ve recruited to target, observed more than the required number of primary endpoints and that gives us at least 90% power. We have very complete, virtually 100%, follow-up data on the primary outcome, which is amputation-free survival. So, we think they’re good-quality data.”
“It’s a very controversial area,” Bradbury opines, making the BASIL-3 first-time data presentations an apt centrepiece for this year’s controversies-focused meeting.
“Although these drug devices have been in practice for probably 15 years now and certainly the last 10 years, it’s been a rocky road for them,” Bradbury explains, citing the paclitaxel mortality debate sparked by the 2018 meta-analysis from Katsanos et al as some important context to the trial. The publication directly affected the progress of BASIL-3, halting proceedings for many months.
“There were concerns around what appeared to be excess mortality across a wide range of industry-funded trials at two and five years, and it’s taken a long-time to resolve that,” Bradbury remarks, providing a brief summary of the six-year saga that a separate session at CX 2024 will address in detail. He references recent reversals of paclitaxel safety warnings by both the US Food and Drug Administration (FDA) and subsequently the UK Medicines and Healthcare products Regulatory Agency (MHRA) that have, “to a great extent”, put any concerns “in the rearview mirror”.
Some of the data being presented at CX 2024 will illuminate the cost effectiveness of the three strategies being compared. Bradbury underlines the “very complicated” nature of health economics and details what the investigators have looked for in BASIL-3. “There’s a close relationship between number of days spent in hospital and overall cost,” he says. “So, if you have a procedure that’s more expensive but reduces the length of the index admission and also subsequent readmissions—because a lot of these patients come back into hospital—that saving, in days in hospital and further interventions, could easily wipe out even quite a large excess of increased cost from the procedure, which in this case being three endovascular strategies would be the device costs.”
Bradbury also considers the global landscape of endovascular care. He underlines variation and unpredictability in endovascular practice across the world, highlighting a need for concrete data in the field.
“Sometimes what you hear at meetings is not really what happens day to day in various vascular centres,” Bradbury points out. The BEST-CLI study, for example, published in the New England Journal of Medicine in 2022, showed a benefit of vein bypass over endovascular in cohort one. “But if you look at the data,” he says, “only half of the patients who were put into the endovascular group actually received a drug device.” This, Bradbury points out, is much lower than might be expected for USA-based practice.
In BASIL-2, on the other hand, which was presented at CX 2023 and simultaneously published in The Lancet, around a third of the patients in the endovascular group had a drug device. “That’s higher than I expected,” he comments.
“It’s really interesting to look at what is custom and practice at the moment in different countries and I think it’s quite difficult to know what that it,” Bradbury highlights.
New data set to aid endovascular decision making
“We think you’ll find the data that we present on clinical effectiveness and also cost-effectiveness very interesting, whatever your views at the moment on the role of these drug devices in the management of CLTI,” Bradbury remarks of the forthcoming presentations. “We very much hope that these new Level 1 data will be of great interest to the Charing Cross audience and help people make decisions in their everyday practice.”
The BASIL-3 podium first is set to take place at 16:10 on Tuesday 23 April as part of the peripheral arterial controversies programme’s inaugural Roger M Greenhalgh late-breaking trials session.
